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Import Of Medical Devices Up By 41% In Fy22

India imported medical devices worth Rs 63,200 crore in 2021-22, up 41 per cent from Rs 44,708 crore in 2020-21, as per a report by AiMeD.

The Commerce Ministry data analysed by the Association of Indian Medical Device Industry (AiMeD) has shown that the imports of medical devices are up by record 41 per cent at Rs 63,200 crore in 2021-22 from Rs 44,708 crore in 2020-21.

Speaking on the rise in imports of medical devices, Rajiv Nath, forum coordinator, AiMeD, said, “NITI Aayog and the Department of Pharmaceuticals recognise that Indian manufacturers have a 12-15 per cent disability factor in manufacturing medical devices in India. We urge the government to neutralise this disability for reduction of medical devices imports in India as was in the case of consumer electronics, including mobile phones and even in the
toy industry.

At present, the duty on Chinese imports ranges mostly from zero to 10 per cent, but the bulk of the items are in the 7.5 per cent category and one item at 25 per cent.

AiMeD urged the government to expedite steps to end the 80 per cent import dependence and an ever-increasing import bill of over Rs 63,200 crore, expedite steps for patients’ protection, stronger quality and safety regulations, price controls to make medical devices and quality treatment accessible and affordable and ethical indigenous manufacturing viable.


Despite the government’s efforts to slow imports from China, the neighbouring nation remained the top import source for India as imports from China grew 48 per cent from Rs 9,112 crore in 2020 -21 to Rs 13,538 crore in 2021-22.

The medical device imports from the USA also increased steeply by 48 per cent to Rs 10,245 crore in 2021-22 from Rs 6,919 crore in 2020-21.

The value of medical devices from China was nearly the same as the combined value of imports from Germany, Singapore, and the Netherlands in 2021-22.


AiMeD said India's rising medical devices imports has hurt small and medium units.

With the government’s push to make India ‘Aatmanirbhar’ in medical device manufacturing, during the pandemic, several local units making masks, PPE kits, thermometers, and gloves mushroomed as there was very high demand.

AiMeD said from 1,200 units, the numbers had gone up to 1,800 during the peak of the Covid-19 pandemic. Slowly, units started to shut down as imports from China kept on rising. Now, it is estimated that there are around 1,500 such units, and many more are on the verge of closing down.

For the beleaguered domestic industry, capacity utilisation had dropped by the October-December quarter of 2021-22. From the peak utilisation levels of 100 per cent, by November 2021, around 33 per cent, or one-third of India’s medical devices making capacity, was estimated to be lying idle. This is even higher currently, as per AiMeD, an umbrella organisation of domestic medical device manufacturers.

AiMeD’s analysis shows India’s top five medical device import sources -- China, USA, Germany, Singapore and the Netherlands --together account for Rs 37,519 crore, or 68 per cent, of the total value of imports.

AiMeD pointed out that among the six major categories of medical devices like Consumables, Disposables, Electronics and Equipments, Implants, IVD Reagent & Surgical Instruments that are imported, the growth has been the highest in the ‘electronics and equipment’ category.

India imported Rs 40,649 crore worth of medical devices that come under this category in 2021-22 against an import worth Rs 4,569 crore in 2016-17.

The import of surgical instruments went up to Rs 1,260 crore from Rs 243 crore during this period. The other categories of products fared like this: IVD reagent (from Rs 361 crore in 2016-17 to Rs 6,564 crore in 2021-22), consumables (from Rs 5,249 crore in 2016-17 to Rs 8,488 crore in 2021-22), implants (from Rs 384 crore to Rs 3,155 crore) and disposables (from Rs 2,061 crore to Rs 3,084 crore).

AiMeD also analysed the top 50 medical device import items from China to identify the areas of greater dependence for India. A bulk of the imported medical devices from China (in value terms) fall in the ‘other items’ sub-sections under various major categories, it finds. AiMeD urged that the government should consider shifting from an 8 Digit HS Code to a 10 Digit HS Code as done by USA and Europe to give more granular data for enabling better analysis and policy making.

"The government needs to take policy decisions as done for Mobile Phone & Consumer Electronic Industry to give level playing field, if not a strategic advantage to domestic manufacturers, while safeguarding consumers or India will remain 80 per cent import dependent which is a high healthcare security risk," Rajiv Nath said. (July 22, 2022)

CDSCO Issues Alert On Baxter’s Blood Purification Device Hemoperfusion Cartridge

The Central Drugs Standard Control Organisation (CDSCO) has issued a medical devices alert on Baxter Healthcare’s Absorba Hemoperfusion Cartridge 300 C and Absorba 300 C, devices used in blood purification, due to presence of particulate matter within the cartridge.

Baxter has informed the CDSCO that it “is issuing an urgent medical device recall for the Adsorba Hemoperfusion Cartridge 300 C and Adsorba 300 C due to the presence of particulate matter within the cartridge”. If the particulate matter is not detected before use, the particles may reach the vascular system of the patient with potential serious adverse health consequence, it added.

However, there have been no complaints or patient injury associated with this issue, said the company in a regulatory filing. The company has also released the batches/lots which were affected, with expiration date ranging between February and October, 2024.

Hemoperfusion is to complement existing blood purification technologies, if the patient has taken life threatening amounts of adsorbable drugs, or is in a deep coma and symptoms such as hypo ventilation, hypotonia, hypothermia, worsening of the clinical state despite conservative medical management, among others.

If the patient has taken drugs of which the amount, composition and kind are unknown and the patient is deeply comatose, hemoperfusion can be considered. The Adsorba has been proven a high degree of efficacy for the drugs including barbiturates, organophosphates, bromo carbamide, paracetamol, ethchlorvynol, paraquat, meprobamate, salicylate, among others.

The use of hemoperfusion as a supplementary treatment does not mean that other conventional methods of treatment should be omitted. Measures such as gastric lovage, establishment of free airway and assisted respiration, controlled electrolyte and water balance, and forced dieresis should be administered whenever indicated. Furthermore, it might be necessary to monitor carefully the blood levels of vital substances or drugs which also could be adsorbed during the hemoperfusion treatment. Access to blood stream for hemoperfusion treatment can be obtained by normal hemodialysis methods.

The company said that any person who has used an affected Adsorba Hemoperfusion Catrdige 300C and Adsorba 300 C, may be affected. CDSCO has said that it has not received any complaints from the market on this issue.

Baxter has sought the customers to return the product to the company directly, if purchased directly from the company, by completing the customer reply form and sending it through email to Baxter. If it has been purchased form a distributor, the company advises the customers to contact the distributor for return and credit.

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